Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was classified as reliable with restrictions becasue the test procedure was in accordance with national standard methods with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: FHSA Regulation 1500.40
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
t-butyl mercaptan (2-methylpropane-2-thiol)
CAS 75-66-1
purity not specified

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Each of six albino rabbits were treated dermally with a single dose of 2000 mg/kg (2.50 ml/kg of the undiluted sample) applied to the hair-clipped skin of the trunk under an occluding prefitted sleeve on each animal. The sleeves were removed 24 hours later.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
The animals were observed for seven days.
Statistics:
not appropriate

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None.
Clinical signs:
The surface of the treated skin became dry and exfoliation began six days after treatment. None of the animals showed any toxic symptoms.
Body weight:
All animals gained body weight during the observation period.
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
Conclusions:
 There were no effects of treatment observed and the LD50 was > 2000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study (pre-guideline study), six rabbits (sex/strain not specified) were treated dermally with a single dose of 2000 mg/kg bw of 2-methylbutane-2-thiol (CAS Number 75-66-1). Doses were applied to the hair-clipped skin of the trunk under an occluding prefitted sleeve. The sleeves were removed 24 hours later and the animals were then observed for seven days. 

There were no effects of treatment observed and the LD50 was >2000 mg/kg bw.

This study received a Klimisch Score of 2 and is classified as reliable with restriction because the test procedure was in accordance with national standard methods with acceptable restrictions.